职位描述:

1. Designing and implementing Innocare phase I-II-III clinical trials of innovative drugs in the field of tumors and autoimmune diseases in China and abroad, based on cGCP, ICH-GCP and other relevant clinical research guidelines;

2. Providing medical monitoring and guidance during clinical trials, including data security audits, participation in safety committees

communicating with regulatory authorities such as FDA on medical research matters, and writing medical research documents for registration;

3. Medical support during the product development phase, including: medical knowledge of product design, medical analysis of competing products, translation and incorporation of medical datapublished in the scientific literature, providing medical rationale interpretation for Research and Development (R&D), and medical information support;

4. Providing medical strategic advice for Innocare product portfolio, project development, and introduction or transfer of researching products (rights and interests);

任职条件:

1. Doctorate in Medicine or in Life Sciences-related majors;

2. At least 5 years of experience in clinical trials in the field of oncology or autoimmune disease treatment, with successful implementation records from protocol design to full completion of Phase I-II-III clinical trials;

3. Comprehensive and in-depth understanding of the whole process of clinical trials of new drugs, including: design, implementation, and statistical/data management of clinical trials; Chinese and international norms and quality criteria; and requirements for pharmacovigilance;

4. Understanding and mastering GCP and ICH guidelines, and being familiar with FDA regulations.